Therapeutic intervention systems employing implantable balloon devices

ABSTRACT

A method of treating a patient comprises: introducing to a physiological locus of said patient a balloon formed from two vacuum thermoformed half-sections of a multilayer film a layer of sealing film and at least one layer of thermoplastic polymer film, wherein the vacuum thermoformed half-sections are bonded together; and the balloon includes an inflation element (such as a self-healing valve and/or an effervescent material) adapted to permit inflation of the balloon at the physiological locus with a fluid.

STATEMENT OF RELATED APPLICATION(S)

This application is a continuation of an claims benefit of U.S. patentapplication Ser. No. 10/815,282, filed on Apr. 1, 2004 and entitled“EXTRUSION LAMINATE POLYMERIC FILM ARTICLE AND GASTRIC OCCLUSIVE DEVICECOMPRISING SAME.”

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to therapeutic intervention methods, such asgastric occlusion methods, employing implantable balloon structuresformed of laminate films, and to related therapeutic devices.

2. Description of the Related Art

In the field of polymeric film technology, involving polymeric sheetstock or web-form material, typically having a thickness of less thanabout 25 mils, there is a need for gas-barrier films.

Such gas barrier films may be employed for containment of a specific gaswhen used to form gas receptacles, or as a packaging, cushioning orpreservative structure (e.g., when fabricated to contain gas speciessuch as oxygen, nitrogen, argon, helium, carbon dioxide, water vapor,etc). Still other applications relate to the prevention or reduction ofgas passage through the film, such as in instances in which anysignificant penetration of gas through the film may adversely impact anarticle, structure, material or region that is isolated from an adversegas environment by the gas barrier film.

In the aforementioned applications, the film material may be susceptibleto forces and consequent stresses that cause failure of the film, e.g.,by cracking, tearing, splitting, stress-softening, embrittlement orother material failure mechanisms.

Specific applications of such gas barrier films may include therequirement of biocompatibility, in which the gas barrier film isrequired to function in or in connection with a physiologicalenvironment, whereby the film may be subjected to exposure to biologicalfluids, variations of temperature, pressure and pH, etc.

There is presently a compelling need in the art for readilymanufacturable, soft and supple yet durable and reliable gas barrierfilms for manufacture of medical devices as well as a wide variety ofother product articles.

SUMMARY OF THE INVENTION

The present invention relates to a gas barrier film, as well as toarticles and devices incorporating such gas barrier film.

In one aspect, the invention relates to a method of therapeuticintervention for treatment of a patient in need of such treatment, saidmethod comprising: introducing to a physiological locus of said patienta balloon formed from two vacuum thermoformed half-sections of amultilayer film comprising: (A) a layer of sealing film, having main topand bottom surfaces; and (B) at least one layer of thermoplastic polymerfilm, disposed along least one of the main top and bottom surfaces ofthe sealing film; wherein the sealing film has a composition andthickness imparting gas barrier character to the multilayer film andwherein the at least one layer of thermoplastic polymer film alone lackssuch gas barrier character; wherein the vacuum thermoformedhalf-sections are bonded together along peripheral portions thereof toform a peripheral edge; and wherein the balloon comprises an inflationelement adapted to permit the inflation of the balloon at saidphysiological locus with a fluid. The inflation element may include, forexample, a self healing valve and/or an effervescent material disposedwithin the balloon.

In another aspect, the invention relates to a method of therapeuticintervention for treatment of a patient in need of such treatment, saidmethod comprising: introducing to a physiological locus of said patienta balloon formed from two vacuum thermoformed half-sections of amultilayer film comprising: (A) a layer of sealing film comprising anyof polyvinylidene chloride and an ethyl vinyl alcohol polymer, havingmain top and bottom surfaces; laminated between (B) a first layer and asecond layer of a thermoplastic polymer film; wherein the sealing filmhas a composition and thickness imparting gas barrier character to themultilayer film and wherein either of the first layer and second layerof thermoplastic polymer film alone lacks such gas barrier character;wherein the vacuum thermoformed half-sections are bonded together alongperipheral portions thereof to form a peripheral edge; and wherein theballoon comprises an inflation element adapted to permit inflation ofthe balloon at said physiological locus with a fluid. The inflationelement may include, for example, a self healing valve and/or aneffervescent material disposed within the balloon.

In another aspect, the invention relates to a gas-retentive enclosurecomprising a multilayer film, wherein the multilayer film comprises:

a layer of sealing film, having main top and bottom surfaces; and

a layer of thermoplastic polymer film, laminated to the layer of sealingfilm, on at least one of the main top and bottom surfaces;

wherein the sealing film has a composition and thickness imparting gasbarrier character to the multilayer film and wherein the layer(s) ofthermoplastic polymer film alone lacks such gas barrier character

In another aspect, the invention relates to a gastric occlusive device,comprising:

-   -   a balloon formed of a multilayer film comprising:        -   a layer of sealing film, having main top and bottom            surfaces;        -   a layer of thermoplastic polymer film, on at least one of            the main top and bottom surfaces of the layer of sealing            film;        -   wherein the sealing film has a composition and thickness            imparting gas barrier character to the multilayer film and            wherein the layer(s) of thermoplastic polymeric material            alone lacks such gas barrier character; and    -   an effervescent material contained in said balloon, and arranged        for contact with introduced liquid reactive with the        effervescent material to liberate gas for inflation of the        balloon.

A still further aspect of the invention relates to a method oftherapeutic intervention for treatment of a patient in need of suchtreatment, such method comprising:

introducing to a physiological locus of a patient in need of suchtherapeutic intervention a balloon formed of a multilayer film, whereinthe multilayer film comprises:

-   -   a layer of sealing film, having main top and bottom surfaces;        and    -   a layer of thermoplastic polymer film, laminated to the layer of        sealing film, on at least one of the main top and bottom        surfaces;    -   wherein the sealing film has a composition and thickness        imparting gas barrier character to the multilayer film and        wherein the layer(s) of thermoplastic polymer film alone lacks        such gas barrier character;        with an effervescent material contained in said balloon, and        arranged for contact with introduced liquid reactive with the        effervescent material to liberate gas for inflation of the        balloon.

As used herein, the term “film” means a material in a sheet or web form,having a thickness of 50 mils (1.270 mm) or less.

As used herein, the term “extrusion laminated” in reference to a film ofthermoplastic material means that such film of thermoplastic material isdeposited as an extruded melt film on (one or both sides of) the sealinglayer film, so that the respective thermoplastic material and sealinglayer films are consolidated with one another under elevated temperatureconditions. The laminate preferably is formed under process conditionsproducing substantially uniform thickness of the multilayer film, with athickness variation across the laminated film desirably being less than20% and more preferably being less than 15% of the total thickness ofthe laminate.

Other aspects, features and embodiments will be more fully apparent fromthe ensuing disclosure and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a gas barrier film according to oneembodiment of the invention.

FIG. 2 is a front elevation view of a gastric occlusive device,according to one embodiment of the invention.

FIG. 3 is a schematic front elevation cross-sectional view of a vacuumthermoforming die for use in forming a balloon article for fabricationof a gastric occlusive device of the type shown in FIG. 2.

FIG. 4 is a schematic cross-sectional elevation view of a radiofrequency (RF) welding operation by which two vacuum thermoformedhalf-sections formed in the assembly of FIG. 3 after being mated withone another for consolidation at an edge seam, are welded under heat andpressure conditions effecting bonding of the half-sections to oneanother.

DETAILED DESCRIPTION OF THE INVENTION, AND PREFERRED EMBODIMENTS THEREOF

The present invention is based on the discovery of a laminatedmultilayer film structure having utility as a gas barrier film, asuseful in the fabrication of a wide variety of end-use articles,including, without limitation, gastric occlusion devices.

Thus, while the invention is described more fully hereinafter withreference to an illustrative gastric occlusive device, as fabricatedfrom the laminated multilayer film of the invention, it will beappreciated that the inventive film is susceptible of a wide variety ofusages, e.g., in applications in which the film must contain a gas atpressure at least equal to pressure of an ambient environment of thearticle incorporating such film, or in which permeation of gas throughthe film would adversely affect a structure, article or material on anopposite side of the barrier film from such gas.

The gas barrier film structure of the invention is a laminate including:

-   -   a layer of sealing film, having main top and bottom surfaces;        and    -   a layer of thermoplastic polymer film, laminated (e.g.,        extrusion laminated) to the layer of sealing film, on at least        one of the main top and bottom surfaces;    -   wherein the sealing film has a composition and thickness        imparting gas barrier character to the multilayer film and        wherein the layer(s) of thermoplastic polymeric material alone        lacks such gas barrier character.

The disclosure of U.S. Pat. No. 6,712,832, issued Mar. 30, 2004 in thename of Tilak M. Shah for “LOW—PRESSURE MEDICAL BALLOONS AND METHOD OFMAKING SAME,” hereby is incorporated herein in its entirety, for allpurposes.

As disclosed in such earlier application Ser. No. 09/977,644, alow-pressure medical balloon can be fabricated by providing a thin filmof thermoplastic polymeric material that is heated to a sufficienttemperature for vacuum forming thereof. A first half-section for theballoon then is formed by subjecting the thermoplastic polymeric film tovacuum suction. A second half-section for the balloon then is formed bysubjecting a same or different thermoplastic polymeric thin film tovacuum suction, following which the first half-section of the balloon isbonded to the second half-section along respective edges thereof toyield the balloon.

Such methodology may be employed to form a low-pressure balloon articleof a non-pillowed, generally spherical or flattened spherical character,in which the respective half-sections of the balloon are readilyfabricated and mated to form the product balloon article. The balloonarticle as thus formed may then be everted (turned inside out) so thatthe free edges (flange or “skirt”) of the seam are disposed in theinterior volume of the balloon.

The laminate of the present invention is formed with an outer layer (onone or both sides of the sealing film) of a thermoplastic polymeric filmmaterial, such as polyurethane elastomer, polyester ether elastomer,polyamide elastomer, etc., having good physical properties for theintended end-use, but which is gas-permeable to an undesired extent, inrespect of its intended end-use application. The thermoplastic polymerfilm may have any suitable thickness, e.g., a thickness in a range offrom about 2.0 mils to about 20 mils (0.0508 mm to 0.508 mm), althoughgreater or lesser thicknesses may be employed in specific applicationsof the invention, e.g., a thickness in a range of from about 2.0 mils toabout 5.0 mils (0.0508 mm to 0.127 mm).

The laminate includes a layer of a sealing film. A layer ofthermoplastic material is laminated, e.g., extrusion laminated, on atleast one of the main top and bottom surfaces of the sealing layer. Thesealing film layer has a composition and thickness imparting gas barriercharacter to the laminated film structure. In other words, the presenceof the sealing film effects a diminution of the gas permeabilitycharacteristics of the laminate (relative to the gas permeabilitycharacteristics of the outer thermoplastic material layer(s) per se), inrespect of particular gas components or gas mixtures of interest, sothat the resulting multilayer laminate is suitable for use as a gasbarrier.

Polyurethane elastomer is a preferred material of construction for theouter layer(s) of the laminated film, although a wide variety of othermaterials, such as polyester ether elastomer, stryenic elastomers,polyamide and polyamide elastomers and other film-forming thermoplasticelastoplastics, including the polymeric families of polyethylene,polypropylene, polyvinylchloride (PVC), polyvinylether (PVE), ethylenevinyl acetate (EVA) polymers, and combinations of two or more of theforegoing, etc., may be employed. The choice of a specific thermoplasticmaterial for a given end use application, and the choice of extrusionlaminating a layer of such thermoplastic material to only one, oralternatively to both, of the surfaces of the sealing film layer, canreadily be made within the skill of the art, and without undueexperimentation, based on the disclosure herein.

The multilayer laminated film of the present invention is readilyprocessed in the manner described in the aforementioned U.S. patentapplication Ser. No. 09/977,644, to form balloon and catheter articlesof widely varying types.

For example, a multilayer extrusion laminated film of the invention maybe utilized to form low-pressure balloons and catheters useful for awide variety of procedures, such as minimally invasive surgery.

In medical balloon usage, it is important that the balloon structurehave uniform wall thickness and concentric expansion during inflation,so that the physiological effect is correspondingly uniform and able tobe well-standardized and quantified.

The multilayer extrusion laminated films of the invention areparticularly useful in the fabrication of balloon articles such as thegastric occlusive device hereinafter more fully described. In suchapplication, the extrusion laminated film can have a thickness in arange of from about 0.5 to about 10 mils (0.0127 mm to 0.254 mm), andmore preferably in a range of from about 2 mils to about 6 mils (0.0508mm to 0.1524 mm), although greater or lesser thicknesses of theextrusion laminated film may be employed, e.g., a thickness in a rangeof from 0.5 to about 50 mils (0.0127 mm to 1.27 mm), as appropriate in aspecific end-use application.

The sealing film layer, on which at least one outer layer ofthermoplastic material is laminated in the laminated film of theinvention, may be of any suitable type that is effective to impart gasbarrier characteristics to the laminate. As indicated, the outer layercan be formed of a material such as a polyurethane elastomer or othersuitable thermoplastic elastomer.

The sealing layer in relation to specific outer layer thermoplasticmaterials can be fabricated of any complementary material imparting gasbarrier characteristics to the overall laminated film that includes theouter layer(s) and the sealing layer. Illustrative sealing layermaterials include polyvinylidene chloride (PVDC), commercially availablefrom Dow Chemical Company under the trademark Saran, polyvinylidenebromide, ethylene vinyl alcohol polymers (conventionally referred to as“EVOH” polymers), etc.

The sealing film can be of any suitable thickness as required for thegas barrier end-use application. Typically, when polyvinylidene chlorideor EVOH polymers are employed to form the sealing film, the sealing filmcan have a thickness on the order of from about 0.2 mil to about 6 mil(0.00508 mm to 0.1524 mm).

In an illustrative embodiment, the outer layer of the extrusion laminateis formed of a sealing layer of polyvinylidene chloride, having athickness in a range of from about 0.25 to about 2.0 mil (0.00635 mm to0.0508 mm), to which a layer of polyurethane elastomer film, having athickness in a range of from about 2.0 mils to about 5.0 mils (0.0508 mmto 0.127 mm), is extrusion bonded.

It will be appreciated that when the multilayer laminate of theinvention features two outer layers of thermoplastic polymeric material,each laminated to the sealing layer on a respective surface of thesealing layer, the outer layers of thermoplastic material may be thesame as or different from one another in composition. For example, apolyurethane elastomeric film may be extrusion laminated to one face ofa polyvinylidene chloride film, and a polyethylene film may be extrusionlaminated to the other face of the polyvinylidene chloride film.

It will also be appreciated that the thermoplastic material layer mayinclude multiple sub-layers, and that the sealing layer may likewiseinclude multiple sublayers, and that these respective sub-layers may becompositionally homogeneous or alternatively varied in composition alongthe successive sub-layers.

The laminate of the invention may be utilized to form a gastricocclusive device, as hereinafter more fully described. The gastricocclusive device is a balloon that is fabricated to contain a charge ofan effervescent material that in the presence of water or moisturereacts to form CO₂ gas. The balloon containing such effervescentmaterial charge can be injected, through the multilayer film via asuitable self-healing seal valve therein, with a requisite amount ofwater or aqueous medium. The injected water or aqueous medium thenreacts with the effervescent material, to generate carbon dioxide as aninflation gas for the balloon.

The balloon of the gastric occlusive device thus is inflated subsequentto being placed in a gastric locus of a patient. The inflated balloonthereafter remains sufficiently gas-tight in character so that theinflated volume of the balloon is relatively constant over an extendedperiod of time.

In one embodiment, the balloon is formed with a degradable seal, whichunder exposure to a physiological environment degrades to permitdeflation of the balloon and removal thereof from a physiological locus.

In one preferred dimensional aspect, the gastric occlusive balloon has adiameter when inflated of 3 to 5 inches, although such balloon in thegeneral practice of the invention may have any suitable size anddimensional characteristics appropriate to the use of the balloon in aspecific application thereof.

In a physiological environment, the balloon article of the inventionmust withstand pressures associated with such environment, e.g.,pressures of 1 to 5 psi. Further, the physiological environment maysubject the balloon article to compressive, tensile and torsionalforces.

Under such conditions in the physiological locus, the multilayerlaminate must be resistant to flex-cracking, particularly when suchconditions involve repeated cycles of shape-deforming stresses. Theselection of film thickness of the laminate is particularly critical inthis respect, since excessively thick films are disproportionately moresusceptible to flex-cracking, particularly at the seams where adjacentpanels or sections of a film are bonded to one another.

Thus, the balloon article incorporates a multilayer laminate that hasdesired characteristics for the intended use application. Thesecharacteristics may variously include softness to the touch (e.g., aShore D hardness of 65 or less), resistance to flex fatigue, andleak-tightness and dimensional stability under the range of pressureconditions that may be encountered in such intended use application.

Balloon or other gas-retentive or gas barrier articles in accordancewith the invention can alternatively be formed using conventionalmultilayer barrier films, which are processed as described herein.Barrier films including at least one layer of urethane material areadvantageously processed as described herein to form balloon articlesfrom half-sections that are produced by vacuum forming, e.g., vacuumthermoforming, and then bonded at their outer periphery to form aballoon article without openings in the weld line or any other locationon the dome of the respective half-sections in the finished article.

Conventional multilayer barrier films of such type may be manufacturedeither by co-extrusion of sealing layer(s) with outer layer(s), with orwithout adhesive, or by preformed film of outer layers adhesivelaminated to preformed film of sealing layers. For example, co-extrudedfilms of 3-4 layers can be utilized.

Referring now to the drawings, FIG. 1 is a perspective view of anextruded laminate film 10 according to one embodiment of the invention.

The extruded laminate film 10 includes outer film layers 14 and 16 ofthermoplastic material, which have been extrusion laminated to a sealinglayer film 12.

The outer film layers 14 and 16 of thermoplastic material may comprise apolyurethane elastomer film, or other thermoplastic elastomer film, orany other thermoplastic material film that is gas-pervious in characterand by itself has inadequate gas barrier character for the desired enduse. The sealing layer, on which the thermoplastic material layers areextrusion laminated, provides a gas barrier film imparting the requisitegas-impervious character to the overall laminate for the intended useapplication.

While the laminate of FIG. 1 is shown as comprising three layers, i.e.,the outer layers of gas-pervious film material and the central layer ofsealing film material, it will be recognized that the invention is notlimited to such three-layer film constructs, but may comprise twolayers, or alternatively more than three layers of material, includingat least one outer layer of gas-pervious film and a sealing film layerimparting gas barrier character to the multilayer laminate. In multiplelayer laminated films having three or more layers, the additional layersmay be formed of any suitable material, to achieve any additionalrequired mechanical or chemical resistance properties, and suchadditional layers may be extrusion laminated over the sealing film layerand/or outer layer(s), during the fabrication of the laminate.

In a specific embodiment, a three-layer film of the type shown in FIG. 1includes outer layers 14 and 16 of polyurethane elastomer, having athickness of about 2 mils (0.0508 mm), and a sealing layer 12 ofpolyvinylidene chloride film having a thickness of about 1.35 mil(0.0343 mm).

FIG. 2 is a front elevation view of a gastric occlusive device,according to one embodiment of the invention.

The gastric occlusion device 20 includes a balloon 18 formed fromhalf-sections 22 and 24, which are joined to one another at edge seam 26to form an enclosed interior volume 28 of the balloon. The seam 26 maybe formed by any suitable type of bonding technique. A preferred bondingtechnique is radio frequency welding, as discussed hereinafter.

The two pieces of the balloon (half-sections 22 and 24) are preferablybonded circumferentially to one another to form a 360° seal having aseam devoid of any neck or opening therein.

The balloon is shown in its inflated form, in which the interior volume28 contains a head piece 30 bonded to an inside surface of the upperballoon half-section 22. Joined to the head piece 30 is a gas pill 32holding an effervescent material. The head piece and laminated film arejoined to one another by any suitable bonding means and/or method, andtheir junction suitably includes a self-healing seal valve through whichwater or moisture or other aqueous medium may be introduced to contactthe effervescent material in the gas pill 32, e.g., from an associatedcatheter or liquid feed tube (not shown in FIG. 2).

The effervescent material in the gas pill 30 can be of any suitable typethat in contact with water, moisture, or physiological media reacts toliberate carbon dioxide or other inflating gas for the balloon, so thatthe balloon is transformed from an initial collapsed (deflated) state tothe inflated state illustratively shown in FIG. 2.

By way of example, the effervescent material can be a mixture ofaspirin, sodium bicarbonate and citric acid, or other suitable materialgenerating CO₂ in the presence of water, moisture or physiologicalmedia.

The balloon may also include a degradable seal if desired, which can besuccessively deteriorated by a physiological environment in which theballoon is deployed, so that the balloon deflates after a predeterminedperiod of time, and can be more easily be removed, e.g., mechanically orphysiologically, from the corporeal locus of deployment.

For example, a degradable seal may be formed of an ethylene vinylacetate (EVA)/hydroxycellulose blended material that is progressivelydegradable to create an opening in the balloon after a prolonged periodof exposure to a physiological environment, at a thickness permittingthe balloon to remain in an inflated state for a period of timesufficient for the desired treatment to be effected. Upon deteriorationof the seal, an opening is produced in the balloon that permits theinflation gas to egress, and the deflated balloon may then be readilyremoved from the corporeal locus in which treatment is being carriedout.

FIG. 3 is a front elevation cross-sectional view of a vacuum formingassembly 50 for forming a balloon article of the type shown in FIG. 2.

The assembly 50 includes a thermoforming die 52. The die has ablock-like body 52 with a generally hemispherical cavity 54 therein,whose surface 60 communicates through gas withdrawal passages thereinwith the gas extraction plenum 56. The gas extraction plenum 56communicates in turn with discharge passage 58. The discharge passage 58can be coupled with a suitable vacuum source (not shown in FIG. 3), suchas a vacuum pump, for extraction of gas from the thermoforming cavitywhen overlaid by the extrusion laminate film 62. Under the negativepressure imposed by the vacuum source, the central portion of themultilayer film 62 is drawn into the die cavity as shown, against thedie cavity surface 60, and the evacuated gas is discharged from the dievia the discharge passage 58 in the direction indicated by arrow A.

The extruded laminate film 62 in such processing is at sufficienttemperature for vacuum thermoforming, i.e., a temperature above thesoftening temperature of the thermoplastic polymeric material. Suchtemperature preferably is above the Vicat softening temperature of thethermoplastic polymeric laminate material, but below the deformationtemperature of such laminate material. The Vicat softening temperatureof polyurethane elastomers, for example, is usually from about 60° toabout 150° C., depending on the nature of the specific polymer involved.

The Vicat softening temperature is readily determinable within the skillof the art without undue experimentation, for any of various othersuitable thermoplastic polymeric materials that may be employed in theextruded laminate.

By applying negative pressure to the mold cavity so that the heated andsoftened thermoplastic polymeric laminate film is induced to conform tothe shape of the mold cavity, the laminate is vacuum-molded to therequired generally hemispherical shape. In lieu of the female moldstructure shown in FIG. 3, a male mold may alternatively be employed toform the respective half-sections of the balloon article.

The first and second half-sections of the balloon can be formedsimultaneously, or they may be formed sequentially. The same sheet orweb stock of extruded laminate material may be employed for suchpurpose, or different sheets of thermoplastic polymeric laminates may beemployed, as illustrated.

After thermo-vacuum molding two half-sections of the balloon by thearrangement shown in FIG. 3, the half-sections can be superimposed andbonded together at their margins (edges) by any of various suitablebonding methods, as for example the radio frequency welding method thatis illustrated schematically in FIG. 4.

FIG. 4 shows a base mold 80 having the superimposed multilayer laminatefilms 62 and 64 arranged in the cavity 82 so that the generallyhemispherical half-sections of such films are in register with oneanother, with the head piece 30 and gas pill 32 assembly therebetween.

The radio frequency welding die 70 is shown disposed above the base mold80 and in position for downward translation in the direction indicatedby arrows M, to weld films 62 and 64 to one another at thecircumferentially extending weld region 66 by contact of thecircumferentially extending welding ring 72 with the superposed filmlayers. Subsequent to such welding, the welded films may be removed fromthe cavity 82, and the welded sphere can be trimmed adjacent the outerperiphery of the weld region 66, to yield the balloon article.

Although radio frequency welding is a preferred technique for bonding ofthe respective half-sections of the balloon to one another, any ofvarious other suitable bonding techniques may be employed in the broadpractice of the present invention, as for example, adhesive bonding,electromagnetic bonding, hot plate welding, impulse heat inductionbonding, insert bonding, spin welding, thermostacking, ultrasonicsealing or vibration welding, or various combinations of two or more ofthe foregoing techniques.

In a preferred aspect, the two half-sections of the balloon are bondedtogether by radio-frequency welding as described in U.S. Pat. No.5,833,915 for “Method of Welding Polyurethane Thin Film,” issued Nov.10, 1998 to the present inventor. The disclosure of such patent herebyis incorporated herein by reference in its entirety, for all purposes.

As discussed, the gas pill 32 containing the effervescent material canbe secured to an interior surface of the balloon. Alternatively, the gaspill can simply be positioned in an unsecured state in the interiorvolume of the balloon. This is acceptable, provided that the gas pill isaccessible to water, moisture or other medium serving to effect reactionof the effervescent material to produce carbon dioxide or other gas forinflation of the balloon in vivo.

As a still further alternative, the balloon article may be fabricatedwith a gas supply tube, or otherwise be constructed so that the balloonis able to be inflated at the locus of use, if required to be deliveredto such locus in an uninflated state.

The balloon article may additionally be fabricated or adapted so that itis readily removable from the body of the patient, e.g., by means of ahook, loop, vacuum suction head or other engagement structure associatedwith a catheter, guide wire, or other extraction device. The extractiondevice in a specific embodiment may be provided with means forpuncturing the inflated balloon in vivo to facilitate its removal fromthe body of a patient.

It will therefore be seen that medical balloon articles are readilyfabricated from multilayer laminates in accordance with the presentinvention, and are suitable for carrying out a wide variety oftherapeutic interventions.

It will be appreciated that the laminate film of the balloon may beutilized as a drug delivery device, with the film being coated on itsoutside surface with a therapeutic agent, e.g., an anti-viral agent, ananti-inflammatory agent, a time-release analgesic formulation, aclotting factor, etc.

The balloon can also in another embodiment be utilized as agas-retentive enclosure, e.g., as a coolant reservoir in which the gasretained in the interior volume of the balloon is water vapor, or othercoolant medium.

Thus, while the invention has been variously described hereinabove withreference to specific aspects, features and embodiments, it will berecognized that the invention is not thus limited, but rather extends toand encompasses other variations, modifications and alternativeembodiments, such as will suggest themselves to those of ordinary skillin the art based on the disclosure herein. Accordingly, the invention isintended to be broadly construed and interpreted, as encompassing allsuch variations, modifications and alternative embodiments, within thespirit and scope of the claims hereinafter set forth.

1. A method of therapeutic intervention for treatment of a patient inneed of such treatment, said method comprising: introducing to aphysiological locus of said patient a balloon formed from two vacuumthermoformed half-sections of a multilayer film comprising: (A) a layerof sealing film, having main top and bottom surfaces; and (B) at leastone layer of thermoplastic polymer film, disposed along least one of themain top and bottom surfaces of the sealing film; wherein the sealingfilm has a composition and thickness imparting gas barrier character tothe multilayer film and wherein the at least one layer of thermoplasticpolymer film alone lacks such gas barrier character; wherein the vacuumthermoformed half-sections are bonded together along peripheral portionsthereof to form a peripheral edge; and wherein the balloon comprises aninflation element adapted to permit the inflation of the balloon at saidphysiological locus with a fluid.
 2. The method of claim 1, wherein theinflation element comprises a self-healing seal valve adapted to permitthe introduction of a fluid into the balloon and retain said introducedfluid within said balloon.
 3. The method of claim 2, further comprisingintroducing said fluid into the balloon through the self-healing valve,and said fluid comprises a liquid or aqueous substance.
 4. The method ofclaim 1, wherein the inflation element comprises an effervescentmaterial disposed within the balloon, the method further comprisingcontacting the effervescent material with a fluid reactive with theeffervescent material to liberate gas for inflation of the balloon atsaid physiological locus.
 5. The method of claim 1, wherein themultilayer film has a thickness of up to about 10 mils.
 6. The method ofclaim 1, wherein the balloon in an inflated state has a diameter in arange of from about 3 inches to about 5 inches
 7. The method of claim 1,wherein each half-section is substantially hemispherical.
 8. The methodof claim 1, wherein at least a portion of said balloon comprises adegradable material that is degradable in exposure to physiologicalcomponents in said gastric cavity, said degradable seal material beingadapted to retain the balloon in an inflated state for a predeterminedperiod of time sufficient for said treatment of said subject and todeflate after said period of time by egress of said inflation mediumthrough the degradable seal material.
 9. The method of claim 1, whereinsaid degradable seal material comprises an ethylene vinylacetate/hydroxycellulose material that is progressively degradable inthe gastric cavity to create an opening in the balloon for deflation ofsaid balloon.
 10. The method of claim 1, wherein the sealing filmcomprises any of polyvinylidene chloride and an ethyl vinyl alcoholpolymer, said at least one layer of thermoplastic polymer film comprisesa first and a second layer of polyurethane, said first layer ofpolyurethane is laminated to the sealing film along both the main topsurface thereof, and said second layer of polyurethane is laminated tothe sealing film along the main bottom surface thereof.
 11. The methodof claim 1, wherein the two half-sections are bonded circumferentiallyto one another such that the peripheral seams forms a 360° seal and theperipheral seam is devoid of any neck or opening therein.
 12. The methodof claim 1, wherein said physiological locus comprises a gastric cavity.13. The method of claim 2, further comprising introducing, to thephysiological locus with the balloon, a fluid supply tubecommunicatively coupled with the self-healing seal valve.
 14. The methodof claim 1, further comprising (A) deflating the balloon and (B)extracting or excreting the balloon from the patient
 15. The method ofclaim 1, wherein the balloon comprises a coating on an exterior surfaceof the balloon, said coating comprising a therapeutic agent.
 16. Themethod of claim 1, wherein the multilayer film comprises a sealing layercomprising any of polyvinylidene chloride and an ethyl vinyl alcoholpolymer, said sealing layer is disposed between a first and a secondthermoplastic polymer film layer comprising polyurethane, and saidsealing layer comprises an adhesive layer disposed between any of (1)the first thermoplastic polymer film layer and the sealing layer, and(2) the second thermoplastic polymer film layer and the sealing layer.17. A method of therapeutic intervention for treatment of a patient inneed of such treatment, said method comprising: introducing to aphysiological locus of said patient a balloon formed from two vacuumthermoformed half-sections of a multilayer film comprising: (A) a layerof sealing film comprising any of polyvinylidene chloride and an ethylvinyl alcohol polymer, having main top and bottom surfaces; laminatedbetween (B) a first layer and a second layer of a thermoplastic polymerfilm; wherein the sealing film has a composition and thickness impartinggas barrier character to the multilayer film and wherein either of thefirst layer and second layer of thermoplastic polymer film alone lackssuch gas barrier character; wherein the vacuum thermoformedhalf-sections are bonded together along peripheral portions thereof toform a peripheral edge; and wherein the balloon comprises an inflationelement adapted to permit inflation of the balloon at said physiologicallocus with a fluid.
 18. The method of claim 17, wherein the inflationelement comprises a self-healing seal valve adapted to permit theintroduction of a fluid into the balloon and retain said introducedfluid within said balloon.
 19. The method of claim 18, furthercomprising introducing said fluid into the balloon through theself-healing seal valve, and said fluid comprises a liquid or aqueoussubstance.
 20. The method of claim 17, wherein the inflation elementcomprises an effervescent material disposed within the balloon, themethod further comprising contacting the effervescent material with afluid reactive with the effervescent material to liberate gas forinflation of the balloon at said physiological locus.
 21. The method ofclaim 17, wherein the thermoplastic polymer film comprises polyurethane.22. The method of claim 17, wherein each half-section is substantiallyhemispherical.
 23. The method of claim 17, wherein at least a portion ofsaid balloon comprises a degradable material that is degradable inexposure to physiological components in said gastric cavity, saiddegradable seal material being adapted to retain the balloon in aninflated state for a predetermined period of time sufficient for saidtreatment of said subject and to deflate after said period of time byegress of said inflation medium through the degradable seal material.24. The method of claim 17, further comprising (A) deflating the balloonand (B) extracting or excreting the balloon from the patient.
 25. Themethod of claim 17, wherein the multilayer film has a thickness of up toabout 10 mils, and the balloon in an inflated state has a diameter in arange of from about 3 inches to about 5 inches.